SciTech Development

SciTech Development, LLC 

Enabling Proven Cancer Drugs

  SciTech Development, LLC is a Michigan based oncology drug development company currently bringing to market proven cancer drugs for diseases with limited therapeutic options. Originally associated with the Karmanos Cancer Institute (KCI) and Wayne State University (WSU), SciTech was tasked with addressing the therapeutic performance limitations of fenretinide; namely, its inherently poor solubility, the associated poor bioavailability and the consequent inability to deliver safe and effective doses. By creating the first ever triglyceride-free intravenous vehicle, the company has successfully completed the task of finally delivering on the promise of fenretinide as an anticancer agent.

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Interested parties, contact:

Earle T. Holsapple III
T: (313) 938-5517
E: ETH (at) SciTechDevelopment (dot) com

Company Highlights

Industry: Pharmaceutical

Drug Product: ST-001 (Proprietary Formulation) = Fenretinide + Delivery

Drug Target: T-cell lymphoma (2 chronic cancer indications); Small cell lung cancer (SCLC); All diseases with limited therapeutic options

Proven Anti-Cancer Drug:
Fenretinide has established efficacy in humans; shown to be safe in 1,000’s of patients

Unique ST-001 Formulation:
Drug delivery of therapeutic doses - safely & effectively

Strategic & Rapid Drug Development:
Existing human efficacy data
Access to NCI data
Streamlined clinical trials design
Fenretinide provided free by NCI
FDA expedited programs anticipated:
  Fast Track designation
  FDA Orphan Drug designation
  Accelerated Approval pathway
  Priority Review designation

Amount of Financing Sought:
$4.9M for completion of clinical trials required for NDA filing

Use of Funds:
cGMP drug manufacture (ST-001) Clinical Trials (Phase I)
FDA compassionate use approval & NDA filings

Exit Strategy:
Targeted acquisition

Time to Market:
3-4 years (unusually short)

The Technology SciTech has developed a unique triglyceride-free drug formulation (ST-001) that finally enables its use by significantly enhancing the bioavailability of fenretinide, a proven anti-cancer drug developed by McNeil Laboratories and later abandoned due to its inherent poor solubility and low bioavailability. SciTech’s patented lipid-based fenretinide safely and effectively achieves therapeutic drug levels necessary for successful cancer treatment.

The Market Opportunity The market opportunity for cancer drugs is vast. SciTech’s initial target markets are T-cell lymphoma ($250M) and Small Cell Lung Cancer (>$700M) for a total addressable market of $950M+. Potential efficacy is anticipated in other cancers.

The Intellectual Property SciTech is the inventor, co-owner and exclusive licensee of U.S. Patent No. 8,709,379 (issued April 29, 2014) titled “Liposomal Nanoparticles and Other Formulations of Fenretinide for Use in Therapy and Drug Delivery”. International patent coverage includes the major global oncology markets: Canada, EU, Australia and New Zealand.

Future Investment Opportunity SciTech will be seeking $4.9M in convertible notes or equity to expand operations and conduct required FDA clinical trials. Key expenditures would include cGMP manufacturing (ST-001), clinical studies, and select hiring.

The FDA Regulatory Strategy Past fenritinide drug studies conducted by McNeil Laboratories, Johnson & Johnson, National Cancer Institute (NCI) and others have generated a large database of public information that allows SciTech to optimize its clinical program (accelerated dose titration designs for oncology clinical trials). FDA Fast Track designation and/or other FDA expedited designations will lead to early drug product launch and added IP protection. SciTech expects to prove the clinical efficacy of its ST-001 drug formulation in <3 years and commence marketing in the unusually rapid time frame of 3-5 years.

The Business Model SciTech will retain a small number of employees primarily to manage operations, manufacturing & outsourced clinical studies (CRO). The company will also enlist regulatory & legal consultants for FDA filings. The company's business model is to rapidly demonstrate ST-001 efficacy in human studies in advance of a potential acquisition by large pharma.